The aim of this study is to investigate the benefits of ARV treatment to patients, to the family members of patients on ARV treatment, and to communities at large. The study also aims to investigate the impact of a peer adherence support and a nutritional intervention on measures of treatment success. To this end, 648 patients who had commenced ARV treatment in the past month at twelve selected health care facilities will be recruited into the study. In addition, 204 randomly sampled households from the communities served by the twelve selected clinics will be recruited into the study. Trained enumerators will at baseline conduct semi-structured interviews with patients and households. Following the baseline survey, patients recruited into the study will be randomly assigned to one of three groups:

Patients receiving ARV treatment and the associated support currently provided in the public sector ARV treatment programme.

Patients receiving (a) plus bi-weekly visits by an experienced ARV patient who has been trained as a peer adherence supporter

Patients receiving (a) and (b) plus a weekly nutritional supplement in the form of two 400g cans of meatballs and spaghetti in tomato sauce The group of 'comparison' households comprises the fourth group. Trained enumerators will conduct follow-up interviews with all patients and households at approximately six- and at twelve-months respectively. In addition, the ARV coordinator and other providers working in the ARV treatment programme at each of the twelve selected health care facilities will be interviewed by trained enumerators, at baseline and again at six- and at twelve-months. Clinical data will be obtained from patient files at baseline and at completion of the study. Using these data, various outcomes of importance to the study will be compared between the four study groups, using experimental and non-experimental methods.

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment only group

Drug: ARV treatment

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme

Active Comparator: 2

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment and ARV peer adherence support group

Behavioral: ARV peer adherence support (PAS)

Adherence support provided during twice weekly visits to the patient by an experienced ART patients who received basic training in ARV peer adherence support

Drug: ARV treatment

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme

Active Comparator: 3

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment, ARV peer adherence support and nutritional support group

Behavioral: ARV peer adherence support (PAS)

Adherence support provided during twice weekly visits to the patient by an experienced ART patients who received basic training in ARV peer adherence support

Dietary Supplement: Nutritional support

Weekly delivery by peer adherence supporter (PAS) of two 400g cans of meatballs and spaghetti in tomato sauce

Drug: ARV treatment

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme

No Intervention: 4

Randomly selected households from the general community served by the selected health facility, excluding households where someone is known to receive ARV treatment - comparison/control group

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821366

Locations

South Africa

Batho clinic

Bloemfontein, Free State, South Africa

MUCPP clinic

Bloemfontein, Free State, South Africa

Tswelepele clinic

Bloemfontein, Free State, South Africa

Refengkhotso clinic

Deneysville, Free State, South Africa

Tshiame clinic

Harrismith, Free State, South Africa

Itumeleng clinic

Jagersfontein, Free State, South Africa

Phomolong clinic

Phomolong, Free State, South Africa

Namahali clinic

Phuthaditjaba, Free State, South Africa

Tseki clinic

Phuthaditjaba, Free State, South Africa

Zamdela clinic

Sasolburg, Free State, South Africa

Matjhabeng clinic

Welkom, Free State, South Africa

Welkom clinic

Welkom, Free State, South Africa

Sponsors and Collaborators

Centre for Health Systems Research & Development, University of the Free State